Device product
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
Z-2118-2020
Product summary
- Event
- Event 85144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280 devices
- Official record key
device-enforcement:Z-2118-2020
Official wording
Reason: An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
Code information: Model Number: UM750 Lot Number: 181183
Distribution pattern: International distribution to the country Japan.
Derived failure modes
-
Unknown
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.